Blog
RSS FeedPosted by Michael Wonder on 21 Mar 2025
Alnylam announces FDA approval of Amvuttra (vutrisiran), the first RNAi therapeutic to reduce cardiovascular death, hospitalisations and urgent heart failure visits in adults with ATTR amyloidosis with cardiomyopathy
20 March 2025 - Only therapeutic approved in the US to address both cardiomyopathy and polyneuropathy manifestations of ATTR amyloidosis. ...
Posted by Michael Wonder on 21 Mar 2025
US FDA approves Tremfya (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease
20 March 2025 - Supported by data from the GALAXI study, Tremfya is the only IL-23 inhibitor to show superiority versus ...
Posted by Michael Wonder on 20 Mar 2025
FDA approves pembrolizumab for HER2 positive gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1
19 March 2025 - Today, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy ...
Posted by Michael Wonder on 19 Mar 2025
Scienture announces the US FDA approval of its NDA for SCN-102 to be launched as Arbli (losartan potassium) 10 mg/mL oral suspension
18 March 2025 - Scienture is pleased to announce the US FDA has approved SCN-102 with the brand name Arbli (losartan ...
Posted by Michael Wonder on 17 Mar 2025
ANI Pharmaceuticals announces FDA approval for expansion of Iluvien label
14 March 2025 - ANI plans to begin marketing Iluvien in the US under the combined label later this year. ...
Posted by Michael Wonder on 14 Mar 2025
ANI Pharmaceuticals announces FDA approval of new purified Cortrophin Gel pre-filled syringe
3 March 2025 - ANI Pharmaceuticals today announced US FDA approval of purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) ...
Posted by Michael Wonder on 13 Mar 2025
Seikagaku announces receipt of a complete response letter concerning the biologics license application in the US for SI-6603 (condoliase)
12 March 2025 - Seikagaku announced today that it has received from the US FDA a complete response letter concerning ...
Posted by Michael Wonder on 10 Mar 2025
US FDA approves Celltrion's Omlyclo (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing Xolair
9 March 2025 - Regulatory approval for interchangeability was supported by positive Phase 3 data demonstrating comparable efficacy and safety profile ...
Posted by Michael Wonder on 07 Mar 2025
scPharmaceuticals announces FDA approval of supplemental new drug application expanding the Furoscix indication to include the treatment of oedema in patients with chronic kidney disease
6 March 2025 - Furoscix is expected to be available for chronic kidney disease patients in April 2025. ...
Posted by Michael Wonder on 07 Mar 2025
Neurotech’s Encelto (revakinagene taroretcel-lwey) approved by the FDA for the treatment of macular telangiectasia type 2
6 March 2025 - Encelto is the first and only FDA approved treatment for macular telangiectasia type 2. ...
Posted by Michael Wonder on 05 Mar 2025
Tevimbra approved in US for first-line treatment of advanced oesophageal squamous cell carcinoma in combination with chemotherapy
4 March 2025 - New indication based on results from a global Phase 3 trial demonstrating significantly improved overall survival ...
Posted by Michael Wonder on 05 Mar 2025
Celltrion receives US FDA approval for Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) biosimilars referencing Prolia and Xgeva
3 March 2025 - The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences from the ...
Posted by Michael Wonder on 03 Mar 2025
FDA approves Genentech’s TNKase in acute ischaemic stroke in adults
3 March 2025 - TNKase (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years. ...
Posted by Michael Wonder on 28 Feb 2025
FDA approves Odactra for the treatment of house dust mite allergy in young children
27 February 2025 - ALK today announced that the US FDA has approved ALK’s Odactra tablet for use in young children ...
Posted by Michael Wonder on 21 Feb 2025
FDA approves first treatment for cerebrotendinous xanthomatosis, a rare lipid storage disease
21 February 2025 - Today, the US FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis in adults. ...